copyright © 2004 wa rutala endoscope reprocessing: current status of disinfection recommendations...

Copyright © 2004 WA Rutala

Endoscope Reprocessing:Current Status of Disinfection Recommendations

William A. Rutala, Ph.D., M.P.H.University of North Carolina (UNC) Health Care

System and UNC at Chapel Hill


Endoscope ReprocessingLecture Goals

Background Infections related to endoscopy Reprocessing of endoscopes and accessories

Cleaning High-level disinfection/sterilization Automated endoscope reprocessing

Quality control


GI ENDOSCOPES

Widely used diagnostic and therapeutic procedure Endoscope contamination during use (109 in/105 out) Semicritical items require high-level disinfection minimally Inappropriate cleaning and disinfection has lead to cross-

transmission In the inanimate environment, although the incidence remains very

low, endoscopes represent a risk of disease transmission


TRANSMISSION OF INFECTION

Gastrointestinal endoscopy >300 infections transmitted 70% agents Salmonella sp. and P. aeruginosa Clinical spectrum ranged from colonization to death (~4%)

Bronchoscopy 90 infections transmitted M. tuberculosis, atypical Mycobacteria, P. aeruginosa Spach DH et al Ann Intern Med 1993: 118:117-128 and Weber DJ, Rutala WA Gastroint Dis 2002


Nosocomial Infections via GI Endoscopes

Observations Number of reported infections is small, suggesting a very low

incidence Endemic transmission may go unrecognized (e.g.inadequate

surveillance, low frequency, asymptomatic infections)Spach DH. Ann Int Med 1993;118:117 and Weber DJ, Rutala, WA. Gastroint Dis 2002


Nosocomial Infections via GI Endoscopes

Infections traced to deficient practices Inadequate cleaning (clean all channels) Inappropriate/ineffective disinfection (time exposure, perfuse

channels, test concentration, ineffective disinfectant, inappropriate disinfectant)

Failure to follow recommended disinfection practices (tapwater rinse)

Flaws is design of endoscopes or AERs


Endoscope Reprocessing: Current Status of Cleaning and Disinfection

Guidelines Multi-Society Guideline, 11 professional organizations, 2003 Society of Gastroenterology Nurses and Associates, 2000 European Society of Gastrointestinal Endoscopy, 2000 British Society of Gastroenterology Endoscopy, 1998 Gastroenterological Society of Australia, 1999 Gastroenterological Nurses Society of Australia, 1999 American Society for Gastrointestinal Endoscopy, 1996 Association for Professional in Infection Control and Epidemiology, 2000 Centers for Disease Control and Prevention, 2004 (in press)


Endoscope Reprocessing, Worldwide

Worldwide, endoscopy reprocessing varies greatly India, of 133 endoscopy centers, only 1/3 performed even a

minimum disinfection (1% glut for 2 min) Brazil, “a high standard …occur only exceptionally” Western Europe, >30% did not adequately disinfect Japan, found “exceedingly poor” disinfection protocols US, 25% of endoscopes revealed >100,000 bacteriaSchembre DB. Gastroint Endoscopy 2000;10:215


Endoscopes


ENDOSCOPE DISINFECTION

CLEAN-mechanically cleaned with water and enzymatic cleaner

HLD/STERILIZE-immerse scope and perfuse HLD/sterilant through all channels for exposure time

RINSE-scope and channels rinsed with sterile water, filtered water, or tap water followed by alcohol

DRY-use forced air to dry insertion tube and channels STORE-prevent recontamination


ENDOSCOPE REPROCESSING

Source of contamination for infections (36 outbreaks) transmitted by GI endoscopes from 1974-2001: Cleaning-3 (12%) Disinfection-19 (73%) Rinse, Dry, Store-3 (12%) Etiology unknown-11



Cleaning (results in dramatic decrease in bioburden, 4-5 log10 reduction) No brushing biopsy channel. (Schousboe M. NZ Med J

1980;92:275) No precleaning before AER. (Hawkey PM. J Hosp Inf

1981;2:373) Biopsy-suction channel not cleaned with a brush.

(Bronowicki JP. NEJM 1997;337:237)


Bacterial Bioburden Associated with Endoscopes

Gastroscope, log10

CFUColonoscope, log10

CFUAfter procedure 6.7 8.5 Gastro Nursing 1998;22:63

6.8 8.5 Am J Inf Cont 1999;27:392

9.8 Gastro Endosc 1997;48:137

After cleaning 2.0 2.3

4.8 4.3

5.1


Viral Bioburden from Endoscopes Used with AIDS Patients Hanson et al. Lancet 1989;2:86; Hanson et al. Thorax 1991;46:410

Dirty Cleaned Disinfected

Gastroscopes HIV (PCR) 7/20 0/20 0/20 HBsAg 1/20 0/20 0/7

Bronchoscopes HIV (cDNA) 7/7 0/7 0/7 HBsAg 1/10 0/10 0/10



Precleaning After removal from patient, wipe the insertion tube with a wet

cloth and alternate suctioning the enzymatic cleaner and air through the biopsy/suction channel until solution clean. The air-water channel is flushed or blown out per instructions.

Transport the endoscope to the reprocessing area. Enyzmatic cleaner should be prepared per instructions. Some

data suggest enzymes are more effective cleaners than detergents. Enyzmatic cleaners must be changed after use.



Cleaning Immerse in a compatible low-sudsing, enzymatic cleaner Wash all debris from exterior by brushing and wiping Remove all removal parts of the endoscope and clean each

reusable part separately After exterior cleaning, brush accessible channels with

appropriate-sized cleaning brush (bristles contact all surfaces)



Cleaning (continued) After each passage, rinse the brush, remove debris before reinserting.

Continue until no visible debris on brush. Attach cleaning adapters for each channel per manufacturer’s

instructions and flush with enzymatic cleaner to remove debris. After cleaning is complete, rinse the endoscope with clean water. Purge water from channels using forced air. Dry exterior of the endoscope

with a soft, lint-free cloth.



CLEAN-mechanically cleaned with water and enzymatic detergent






Source of contaminations for infections (36 outbreaks) transmitted by GI endoscopes from 1974-2001: Cleaning-3 (12%) Disinfection-19 (73%) Rinse, Dry, Store-3 (12%) Etiology unknown-11


ENDOSCOPE REPROCESSINGUnacceptable Disinfectants for HLD

Benzalkonium chloride Iodophor Hexachlorophene Alcohol Chlorhexidine gluconate Cetrimide Quaternary ammonium compounds Glutaraldehyde (0.13%) with phenol



Inappropriate disinfectants Benzalkonium chloride (Greene WH. Gastroenterol 1974;67:912) 70% alcohol (Elson CO. Gastroenterol 1975;69:507) QUAT (Tuffnell PG. Canad J Publ Health 1976;67:141) Hexachlorophene (Dean AG. Lancet 1977;2:134) Hexachlorophene (Beecham HJ. JAMA 1979;1013) 70% alcohol (Parker HW. Gastro Endos 1979;25;102) Povidone-iodine (Low DE. Arch Intern Med 1980;1076) Cetrimonium bromide. (Schliessler KH. Lancet 1980;2:1246)



Inappropriate disinfectants 3% hexachlorophene. (Schousboe M. NZ Med J 1980;92:275) 0.5% CHG in alcohol, 0.015% CHG and 0.15% cetrimide; 87 s

exposure to 2% glut. (Hawkey PM. J Hosp Inf 1981;2:373) 1% Savlon (cetrimide and CHG).(O’Connor BH. Lancet 1982;2:864) 0.0075% iodophor. (Dwyer DM. Gastroint Endosc 1987;33:84) 0.13% glut with phenol. (Classen DC. Am J Med 1988;84:590) 70% ethanol for 3 min. (Langenberg W. J Inf Dis 1990;161:507)



Inappropriate disinfection Air/water channel not exposed to glut. (Birnie GG. Gut

1983;24:171) Air/water channel not exposed to glut. (Cryan EMJ. J Hosp Inf

1984;5:371) No glut (water only) between patients. (Earnshaw JJ. J Hosp Inf

1985;6:95)


High Level Disinfection of “Semicritical Objects”

Exposure Time > 12 m-30m, 20oCGermicide Concentration_____Glutaraldehyde > 2.0%Ortho-phthalaldehyde (12 m) 0.55%Hydrogen peroxide* 7.5%Hydrogen peroxide and peracetic acid* 1.0%/0.08%Hydrogen peroxide and peracetic acid* 7.5%/0.23%Hypochlorite (free chlorine)* 650-675 ppmGlut and phenol/phenate** 1.21%/1.93%___*May cause cosmetic and functional damage; **efficacy not verified


New FDA-Cleared Sterilants

“Old” > 2% Glut, 7.5% HP, 1.0% HP and 0.08% PA

New 1.21% glut and 1.93% phenol/phenate (HLD-20 m at 25oC) 0.55% ortho-phthalaldehyde (HLD-12 m) 7.35% HP and 0.23% PA (HLD-15 m) 2.5% Glut (HLD-5 m at 35oC) Hypochlorite (650-675ppm free chlorine)

Ensure antimicrobial activity and material compatibility


Glutaraldehyde

Advantages Numerous use studies published Relatively inexpensive Excellent materials compatibility

Disadvantages Respiratory irritation from vapor Pungent and irritating odor Relatively slow mycobactericidal activity Coagulate blood and fix tissues to surfaces Allergic contact dermatitis


Ortho-phthalaldehyde

Advantages Fast acting HLD No activation Excellent materials compatibility Not a known irritant to eyes and

nasal passages Weak odor No ACGIH or OSHA limit

Disadvantages Stains protein gray Cost ($30/gal); but lower

reprocessing costs-soak time, devices per gal

Slow sporicidal activity Hypersensitivity in some patients

with a history of bladder cancer


Ortho-phthalaldehyde (OPA)New Contraindications for OPA

Repeated exposure to OPA, following manual reprocessing of urological instruments, may have resulted in hypersensitivity in some patients with a history of bladder cancer undergoing repeated cystoscopy.

Out of approximately 1 million urological procedures, there have been reports of 24 patients who have experience ‘anaphylaxis-like’ reactions after repeated cystoscopy (typically after 4-9 treatments).

Risk control measures: residues of OPA minimized; and contraindicated for reprocessing of urological instruments used on patients with history of bladder cancer.


Minimum Effective Concentration (MEC)High Level Disinfectant (HLD)

Dilution of HLD occurs during use Test strips are available for monitoring MEC For example, test strips for glutaraldehyde monitor 1.5% Test strip not used to extend the use-life beyond the

expiration date (date test strips when opened) Testing frequency based on how frequently the solutions

are used (used daily, test at least daily) Record results





RINSE-scope and channels rinsed with sterile water, filtered water, or tap water followed by alcohol. Inadequate rinsing of HLD has caused colitis.




Rinse, Dry, Store Irrigating water bottle. (Doherty DE. Dig Dis Sci

1982;27:169) Inadequate drying (no alcohol). (Allen JI. Gastroenterol

1987;92:759) Inadequate drying (no alcohol). (Classen DC. Am J Med

1988;84:590)






DRY-purge channels with air, flush with alcohol (assists drying), purge channels with air, dry the exterior

STORE-prevent recontamination






DRY-use forced air to dry insertion tube and channels STORE-prevent recontamination (e.g., hang the

endoscope vertically in a cabinet or clean area)


Nosocomial Outbreaks via GI EndoscopesInfections Associated with Accessories

Infections associated with biopsy forceps Contaminated biopsy forceps. (Dwyer DM. Gastroint Endosc 1987;33:84) Contaminated biopsy forceps (no cleaning between cases). Graham DY.

Am J Gastroenterol 1988;83:974) Biopsy forceps not sterilized (glut exposed,? time) Bronowicki JP. NEJM

1997;334:237) Reusable endoscopic accessories that break the mucosal barrier

should be mechanically cleaned and sterilized between patients


Automated Endoscope Reprocessors (AERs)

Advantages: automate and standardize reprocessing steps, reduce personnel exposure to chemicals, filtered tap water

Disadvantages: failure of AERs linked to outbreaks, does not eliminate precleaning, does not monitor HLD concentration

Problems: incompatible AER (side-viewing duodenoscope); biofilm buildup; contaminated AER; inadequate channel connectors

MMWR 1999;48:557. Used wrong set-up or connector Must ensure exposure of internal surfaces with HLD/sterilant


Disinfection of Emerging Pathogens


Disinfection and Sterilization of Emerging Pathogens

Hepatitis C virus Clostridium difficile Cryptosporidium Helicobacter pylori E.coli 0157:H7 SARS coronavirus Noroviruses Antibiotic-resistant microbes (MDR-TB, VRE, MRSA) Creutzfeldt-Jakob disease (no brain, eye, spinal cord contact)


Disinfection and Sterilization of Emerging Pathogens

Standard disinfection and sterilization procedures for patient care equipment are adequate to sterilize or disinfect instruments or devices contaminated with blood and other body fluids from persons infected with emerging pathogens


ENDOSCOPE SAFETYQuality Control

Ensure protocols equivalent to guidelines from professional organizations (APIC, SGNA, ASGE)

Are the staff who reprocess the endoscope specifically trained in that job?

Are the staff competency tested at least annually? Conduct IC rounds to ensure compliance with policy Consider microbiologic sampling of the endoscope


Conclusions

Endoscopes represent a nosocomial hazard Proper cleaning and disinfection will prevent nosocomial

transmission Current guidelines should be strictly followed Compliance must be monitored Safety and efficacy of new technologies must be validated


Endoscope ReprocessingLecture Goals

Background Infections related to endoscopy Reprocessing of endoscopes and accessories

Cleaning High-level disinfection/sterilization Automated endoscope reprocessing

Quality control


Thank you


References Rutala WA, Weber DJ. Disinfection of endoscopes: Review of new chemical

sterilants for high-level disinfection. Infect Control Hosp Epidemiol 1999;20:69-76.

Nelson DB, Jarvis WR, Rutala WA, et al. Multi-society guideline for reprocessing flexible gastrointestinal endoscopes. AJIC 2003;31:309-315.

Posters: www.olympusamerica.com/msg_section/msg_Reprocessing.asp Questions/Slides: www.disinfectionandsterilization.org (WA Rutala) Weber DJ, Rutala WA, DiMarino AJ. Prevention of infection following

gastrointestinal endoscopy. In DiMarino AJ. Gastro Dis. 2002;87-107 Rutala WA, Weber DJ. Reprocessing endoscopes: United States perspective.

J Hosp Infect 2004;56:S27-S39.

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